At a Glance
- Tasks: Ensure quality compliance and drive continuous improvement in a dynamic environment.
- Company: Join a leading company making a global impact in health and safety.
- Benefits: Competitive pay, remote work flexibility, and opportunities for professional growth.
- Other info: Diverse workplace with a commitment to equality and career advancement.
- Why this job: Make a real difference by ensuring quality in life-changing products.
- Qualifications: 5+ years in QA/QC with a relevant degree; strong analytical and problem-solving skills.
The predicted salary is between 54000 - 60000 £ per year.
Location: Basingstoke (Remote with 1x month on-site meeting attendance required)
Pay Rate: £27.00 per hour
Contract Duration: 9 months initially (40 hours per week)
Start Date: ASAP
Position Overview
Are you looking to take the next step in your quality career and make a lasting impact on a global scale? We are seeking a high-performing Q&RA Engineer II to join our team. In this role, you will play a vital part in ensuring quality compliance across our operations, helping to deliver life-changing products that make the world healthier, cleaner, and safer.
As a Quality Engineer, you will provide critical quality oversight through detailed documentation reviews, process monitoring, and close cross-functional collaboration. This position is ideal for an experienced professional looking to champion compliance, lead major quality investigations, and drive continuous improvement initiatives.
Key Responsibilities
- Compliance & Audits: Support and maintain robust compliance with GMP/GxP, ISO, and global regulatory requirements. Conduct and support both internal and external audits and regulatory inspections.
- Investigations & CAPA: Investigate complex quality issues, lead root-cause analysis efforts, and collaborate across departments to drive effective corrective and preventive actions (CAPA).
- Documentation & Change Control: Author, review, and approve critical quality documentation (including SOPs and investigation reports) and manage change control activities.
- Data & Metrics: Perform advanced data analysis, trending, and reporting of quality metrics to support system enhancements and continuous improvement initiatives.
Requirements & Qualifications
- Education: Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years of experience in QA/QC OR an Advanced degree with 3+ years of relevant experience.
- Experience: Proven background working in highly regulated industries (Pharmaceutical, Medical Device, or Biotech preferred). Comprehensive experience with Enterprise Quality Management Systems (EQMS), Document Control Systems, CAPA processes, deviation management, and change control. Demonstrated expertise in advanced root cause analysis, investigation techniques, and corrective action implementation. Experience actively conducting and hosting internal/external audits and regulatory inspections. Strong proficiency in statistical analysis, data trending, and quality metrics reporting. Project management experience is highly preferred.
- Knowledge, Skills & Abilities: Deep knowledge of GMP/GxP regulations, ISO standards (such as 9001 and 13485), and other relevant quality system requirements. Strong grasp of risk assessment methodologies and continuous improvement tools. Advanced technical writing skills for authoring precise SOPs and investigation reports. Exceptional problem-solving abilities, high attention to detail, and strong interpersonal/communication skills. Ability to work independently, guide cross-functional teams, and work in manufacturing environments with appropriate PPE as needed.
Interview Process
- Stage 1: 30-minute initial interview.
Note: A standard background check is required for the successful candidate.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.
Q&RA Engineer II employer: Randstad Engineering
Join a forward-thinking company that prioritises quality and regulatory excellence while offering a flexible remote work environment in Basingstoke. With a strong commitment to employee development, you will have the opportunity to lead impactful quality initiatives and collaborate with cross-functional teams, all while contributing to life-changing products that enhance global health and safety. Our inclusive work culture fosters innovation and continuous improvement, making it an ideal place for professionals eager to advance their careers in a meaningful way.
StudySmarter Expert Advice🤫
We think this is how you could land Q&RA Engineer II
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about letting people know you’re on the hunt for a Q&RA Engineer II role. You never know who might have the inside scoop on an opportunity!
✨Tip Number 2
Prepare for those interviews! Research the company and its products, especially their compliance and quality standards. Be ready to discuss how your experience aligns with their needs, particularly in GMP/GxP and ISO regulations.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, share specific examples of how you've tackled quality issues or led investigations. Highlight your ability to drive CAPA processes and continuous improvement initiatives.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team and making a difference in quality compliance.
We think you need these skills to ace Q&RA Engineer II
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Q&RA Engineer II role. Highlight your experience in quality compliance, audits, and CAPA processes. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality and regulatory affairs. Share specific examples of how you've driven continuous improvement in past roles.
Showcase Your Technical Skills:Don’t forget to highlight your technical writing skills and experience with EQMS and ISO standards. We’re looking for someone who can author precise SOPs and navigate complex quality systems effortlessly.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates during the process!
How to prepare for a job interview at Randstad Engineering
✨Know Your Regulations
Make sure you brush up on GMP/GxP and ISO standards before the interview. Being able to discuss these regulations confidently will show that you understand the compliance landscape and are ready to tackle quality challenges head-on.
✨Prepare for Audits
Since you'll be involved in audits and inspections, think about your past experiences with them. Be ready to share specific examples of how you've conducted or supported audits, and what you learned from those experiences.
✨Showcase Your Problem-Solving Skills
Be prepared to discuss complex quality issues you've investigated. Highlight your root-cause analysis techniques and how you implemented corrective actions. This will demonstrate your critical thinking and ability to drive improvements.
✨Data is Key
Familiarise yourself with data analysis and quality metrics reporting. Bring examples of how you've used data to support system enhancements or continuous improvement initiatives. This will show your analytical skills and commitment to quality.
